Description

Sunitinib n-Oxide CAS NO 356068-99-0 is a key metabolite and reference standard of the multi-targeted receptor tyrosine kinase inhibitor, Sunitinib. This compound is of critical importance for pharmaceutical research and development, particularly in the areas of drug metabolism and pharmacokinetic (DMPK) studies. It is primarily utilized by research institutions, pharmaceutical companies, and contract research organizations (CROs) engaged in oncology drug development and analytical method validation.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Sunitinib and its metabolites in biological matrices.
• Drug Metabolism Studies: Essential for investigating the metabolic pathways, bioavailability, and clearance mechanisms of Sunitinib in preclinical and clinical research.
• Analytical Method Development: Used to develop, validate, and calibrate high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS/MS) methods.
• Impurity Profiling: Acts as a specified impurity standard for quality control in the manufacturing of Sunitinib active pharmaceutical ingredient (API) to ensure compliance with ICH guidelines.
• Pharmacological Research: Employed in studies to understand the activity, toxicity, and overall pharmacological profile of Sunitinib metabolites.

Basic Information

Product Name	Sunitinib n-Oxide
CAS No.	356068-99-0
Molecular Formula	C₂₂H₂₇FN₄O₃
Molecular Weight	414.47 g/mol
Synonyms	Sunitinib N-Oxide; SU11248 N-Oxide; N-Desethyl Sunitinib N-Oxide; (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide N-Oxide; Sunitinib Metabolite N-Oxide; PF-00562271; SU 11248 N-Oxide
EINECS	Contact for details

Quality Control

Our Sunitinib n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established in-house reference standards. Our quality commitment ensures the material is suitable for its intended use in regulatory submission support and critical research applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to orange solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH limits

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.